Famotidine

Manufacturer: DISCOUNT DRUG MART | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date: 2018-09-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:56:47

Label at a glance#

ProductFamotidine

Active ingredientFAMOTIDINE

Label structure12 sections

Indications and uses

relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Dosage and administration

Famotidine USP, 10 mg adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor Famotidine USP, 20 mg adults and children 12 years and over: to reli...

Storage and handling

store at 20° to 25° C (68° to 77° F) protect from moisture read the directions and warnings before use keep the carton. It contains important information.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-406-7984

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine, USP 10 mg

Famotidine, USP 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

relieves heartburn associated with acid indigestion and sour stomach
prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

Famotidine USP, 10 mg

with other acid reducers
if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Famotidine USP, 20 mg

with other acid reducers
if you have kidney disease, except under the advice and supervision of a doctor.
if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating, or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop use and ask a doctor if

OTC - STOP USE SECTION

your heartburn continues or worsens
you need to take this product for more than 14 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Famotidine USP, 10 mg

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn
- do not use more than 2 tablets in 24 hours
children under 12 years: ask a doctor

Famotidine USP, 20 mg

adults and children 12 years and over:
- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
- do not use more than 2 tablets in 24 hours
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 20° to 25° C (68° to 77° F)
protect from moisture
read the directions and warnings before use
keep the carton. It contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY DRUG MART-FOOD FAIR
MEDINA, OHIO 44256

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug
mart
FOOD FAIR

MAY CONTAIN
ANTI-THEFT
DEVICE

Original Strength
ACID CONTROLLER
Famotidine Tablets, USP 10 mg

Acid Reducer
Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

*COMPARE TO THE ACTIVE INGREDIENT OF ORIGINAL STRENGTH PEPCID AC^®

30 TABLETS

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug
mart
FOOD FAIR

MAY CONTAIN
ANTI-THEFT
DEVICE

Maximum Strength
ACID CONTROLLER
Famotidine Tablets, USP 20 mg

Acid Reducer
Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

*COMPARE TO THE ACTIVE INGREDIENT OF MAXIMUM STRENGTH PEPCID AC^®

25 TABLETS

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
199047	famotidine 10 MG Oral Tablet	PSN	3
310273	famotidine 20 MG Oral Tablet	PSN	3
199047	famotidine 10 MG Oral Tablet	SCD	3
310273	famotidine 20 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FAMOTIDINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae	Product name	7	20260317
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
cf645750-2e70-f6e1-c05a-a52847def5dd	Product name	9	20250312
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-036-25	2020-01-31	C162847	48780-1	9d75b9d1-13bf-f424-e053-dadaa90a57ce	Famotidine
53943-037-31	2020-01-31	C162847	48780-1	9d75b9d1-13bf-f424-e053-dadaa90a57ce	Famotidine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-036-25	Famotidine	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		3
53943-037-31	Famotidine	25 in 1 BOTTLE	TABLET, FILM COATED	25		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-036	FAMOTIDINE TABLET, FILM COATED [DISCOUNT DRUG MART ]	3	Legacy NDC, 1 package rows	20180914_701aae20-f39b-4bba-9ab0-1ce622a5e309.zip
53943-037	FAMOTIDINE TABLET, FILM COATED [DISCOUNT DRUG MART ]	3	Legacy NDC, 1 package rows	20180914_701aae20-f39b-4bba-9ab0-1ce622a5e309.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

Famotidine
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (1200000 MW)
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53943-036	53943-036-25
53943-037	53943-037-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FAMOTIDINE	5QZO15J2Z8	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)	RFW2ET671P	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FAMOTIDINE	5QZO15J2Z8	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYDROXYPROPYL CELLULOSE (1200000 MW)	RFW2ET671P	IACT
STARCH, CORN	O8232NY3SJ	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090283-001	FAMOTIDINE	FAMOTIDINE	10MG	TABLET / ORAL			2009-11-17
A090283-002	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2009-11-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090283-001	FAMOTIDINE	10MG	TABLET / ORAL	2009-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090283-002	FAMOTIDINE	20MG	TABLET / ORAL	2009-11-17	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fcef5054-a41e-4fac-a086-b86d7844570a			701aae20-f39b-4bba-9ab0-1ce622a5e309	2018-09-10	Warnings	Exact identifier spl id: fcef5054-a41e-4fac-a086-b86d7844570a spl set id: 701aae20-f39b-4bba-9ab0-1ce622a5e309

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.